by Xunyao Fu, PhD.
On March 11, 2019, the first amendment of Taiwan’s Regulation of New and Existing Chemical Substances (新化學物質及既有化學物質資料登錄辦法) was published by Environmental Protection Administration (EPA) Order No. 1088000098.
The amendment designated 106 Stage 1 existing chemical substances which are subject to standard registration. The central competent authority screened the 27,000 chemical substances which completed Phase 1 registration by factors such as wide domestic circulation, high potential hazard and/or lack in mastery of information and selected 106 existing chemical substances for Stage 1. The registration deadline for the selected chemical substances varies due to the tonnage of Phase 1 registration:
|Time for obtaining Phase 1 registration number||Annual tonnage band for Phase 1 registration||Registration deadline|
|Before 12/31/2019||>=1 tonne but <100 tonnes||12/31/2022|
|After 1/1/2020||>=1 tonne but <100 tonnes||Within 3 years since January 1 of the next year after Phase 1 registration number is obtained.|
|>=100 tonnes||Within 2 years since January 1 of the next year after Phase 1 registration number is obtained.|
|Not specified||<1 tonne for Phase 1 registration, but >=1 tonne in reality before 12/31/2019||12/31/2022|
|<1 tonne for Phase 1 registration, but >=1 tonne in reality after 1/1/2020||Within 3 years since January 1 of the next year after it reaches 1 tonne.|
Additionally, the amendment also specifies that Phase 1 registration for existing chemical substances should be carried out within 6 months when chemicals manufactured/imported reach 100 kg/year. Only the registration number is given upon approval of the registration (for both new and existing chemical substances registration) instead of issuance of a registration certificate in order to save the cost or registration.
Taiwan’s EPA and Ministry of Labor (MOL) both administer chemical substances registration and jointly review the registration process in a single window system. In order to harmonize the requirements under the relevant regulations administered by the two agencies, the amendment standardized the tonnage limit for hazard and exposure assessments from 1000 tonnes/year to 10 tonnes/year. To reduce the burden on registrants, the amendment also requires an annual report for the registered chemical substance to be submitted beginning April 1, 2020 between April 1 to September 30 every year, which is the same time period for the priority management chemicals administered by MOL.
The Regulation took effect immediately upon publication.
Recommended Action Items
- Read through the Regulation to understand all of the changes;
- Check if your substances are on the list of existing chemical substances subject to standard registration.
Please read our previous blog articles for additional background information:
- Taiwan Drafts Amendment on Regulation of New and Existing Chemical Substances Registration https://msc.ul.com/en/resources/article/taiwan-drafts-amendment-on-regulation-of-new-and-existing-chemical-substances-registration/
EPA News on the promulgation of the Amendment of Regulation of New and Existing Chemical Substances Registration, March 11, 2019. (Source is only available in Traditional Chinese) https://enews.epa.gov.tw/enews/fact_Newsdetail.asp?InputTime=1080311161024
Amendment of Regulation of New and Existing Chemical Substances Registration (新化學物質及既有化學物質資料登錄辦法修正條文) (Source is only available in Traditional Chinese) https://gazette2.nat.gov.tw/EG_FileManager/eguploadpub/eg025044/ch07/type1/gov60/num14/Eg.htm
Regulation of New and Existing Chemical Substances Registration (新化學物質及既有化學物質資料登錄辦法) https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=O0060043
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Toxic and Concerned Chemical Substances Control Act
Existing Chemical Substances
New Chemical Substances